FDA device listing
ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC,ePM Series Patient…
FDA device listing 1340664658 · SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Key facts
| Proprietary names | ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC,ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M) |
|---|---|
| Owner/operator | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| Owner/operator number | 9058402 |
| Premarket submissions | K191769 |
| Product codes | DQA, DRT, DSI, DSK, DXN, FLL, MHX, MLD |
| Device names | DQA - Oximeter, DRT - Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), DSI - Detector And Alarm, Arrhythmia, DSK - Computer, Blood-Pressure, DXN - System, Measurement, Blood-Pressure, Non-Invasive, FLL - Continuous Measurement Thermometer, MHX - Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), MLD - Monitor, St Segment With Alarm |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1025, 870.1110, 870.1130, 870.2300, 870.2700, 880.2910 |
| Review panels | Cardiovascular, General Hospital |
| Registered establishments | Shenzhen Mindray Bio-Medical Electronics Co.,LTD, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
| Establishment registrations | 3007603826, 3009156722 |
| FEI numbers | 3007603826, 3009156722 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database